NCT02294396

Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 649 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.

Detailed description

This was a multicenter, open-label study to evaluate the safety and efficacy of add-on therapy with antimuscarinics in patients with OAB treated with mirabegron. The total duration of the study period was 54 weeks in total, comprising a 2-week screening period and a 52-week treatment period. Patients who met the eligibility criteria for provisional enrollment received orally the study drug for the screening period (mirabegron 50 mg) once daily after breakfast for 2 weeks. Patients who met the eligibility criteria after the screening period were randomized to solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg or tolterodine 4 mg in a 1:1:1:1 ratio, and received orally mirabegron 50 mg and antimuscarinics for 52 weeks. At week 8 visit, the dose of all antimuscarinics except for tolterodine could be increased by 2-fold (solifenacin 10 mg, propiverine 40 mg or imidafenacin 0.4 mg) if a patient met the following criteria: (1) had no response to the study drugs; (2) was considered by the investigator to have no safety concerns; and (3) agreed to increase the dose. However, in the event of AEs after the dose was increased, it could be reduced to the level before the increase. A dose increase for a second time after dose reduction was not permitted.

Conditions

• Overactive Bladder (OAB)

Interventions

Type	Name	Description
DRUG	Mirabegron tablet	orally administered at a dose of 1 tablet once daily after breakfast
DRUG	Solifenacin tablet	orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets)
DRUG	Propiverine tablet	orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner)
DRUG	Imidafenacin tablet	orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner)
DRUG	Tolterodine capsule	orally administered at a dose of 1 capsule once daily after breakfast (could not be increased)

Timeline

• Start date: 2014-10-28
• Primary completion: 2016-09-07
• Completion: 2016-09-07
• First posted: 2014-11-19
• Last updated: 2024-10-31
• Results posted: 2018-12-24

Locations

7 sites across 1 country: Japan